Description:
To tested if the adding of consolidative SBRT to TKI in EGFR mutated patients with less than
or equal to 5 metastatic sites (primary + 5) will improve progression free survival (PFS)
compared to TKI alone.
Title
- Brief Title: Stereotactic Body Radiation Therapy (SBRT) in Newly Diagnosed Advanced Staged Lung Adenocarcinoma (Sindas)
- Official Title: Tyrosine-kinase Inhibitor (TKI) With or Without SBRT in Newly Diagnosed EGFRm Advanced Staged Lung Adenocarcinoma
Clinical Trial IDs
- ORG STUDY ID:
2016 15-1
- NCT ID:
NCT02893332
Conditions
- Stage IV EGFR Mutated Non-Small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
TKI (Gefitinib or Tarceva ) | | TKI with SBRT |
Purpose
To tested if the adding of consolidative SBRT to TKI in EGFR mutated patients with less than
or equal to 5 metastatic sites (primary + 5) will improve progression free survival (PFS)
compared to TKI alone.
Detailed Description
This protocol is a randomized phase III trial of TKI versus consolidative Stereotactic Body
Radiation Therapy (SBRT) plus TKI for patients with Stage IV non-small cell lung cancer
(NSCLC).
Prior to accrual on the trial, patients with Stage IV NSCLC will be tested with positive EGFR
mutation. Patients who with fewer than or equal to 5 sites of oligometastatic disease will be
randomized toTKI or consolidative SBRT to all sites of disease (followed by TKI at the
medical oncologist's discretion). Choices of TKI will be determined by the medical oncologist
based on clinical appropriateness.
Trial Arms
Name | Type | Description | Interventions |
---|
TKI without SBRT | Active Comparator | Newly diagnosed Patients will be placed on EGFR-TKI, ,Gefitinib 250mg po qd or Tarceva 150mg po qd for their metastatic EGFR-mutant stage IV oligometastatic disease.
The oligometastatic disease will not receive SBRT | - TKI (Gefitinib or Tarceva )
|
TKI with SBRT | Experimental | experimental: Oligometastatic Non-Small Cell Lung Cancer Newly diagnosed patients will be placed on EGFR-TKI, Gefitinib 250mg po qd or Tarceva 150mg po qd, for their metastatic EGFR-mutant stage IV oligometastatic disease. All patients will TKI, Gefitinib 250mg po qd or Tarceva 150mg po qd, and SBRT at the same time.
SBRT to up to 5 sites. The SBRT dose range from 5 Gy per fraction to 8 Gy per fraction. SBRT deliver within 5 fractions. | - TKI (Gefitinib or Tarceva )
|
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed metastatic lung adenocarcinoma (recurrent or de novo) harboring
sensitizing EGFR mutations (L858R, exon 19 deletion, G719A, L861Q, S768I, exon 19
insertions) with oligometastatic disease (≤5 discrete lesions of disease irrespective
of location, inclusive of the primary lesion):
- all sites of disease must be amenable to definitive treatment with a local
therapy (surgical resection, stereotactic radiosurgery, ablation and conventional
radiation therapy) as determined by surgery, interventional radiology and
radiation oncology
- all intrathoracic lymph nodes (including hilar, mediastinal, and supraclavicular
nodal disease) are considered 1 discrete lesion.
- No brain metastasis is allowed.
- Patients already started on erlotinib are eligible as long as their sites of disease
are determined to be eligible for definitive local therapy by consensus of the
principal investigators within 12 weeks of the patient first taking erlotinib.
- Lung adenocarcinoma histology confirmed
- Karnofsky Performance Status ≥ 70%
- Adequate bone marrow, liver and renal function, as specified below:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
- Hemoglobin ≥ 8 g/dL
- Platelets ≥ 100 x 109/L
- Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except for patients
with documented Gilbert's Syndrome)
- AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present
- Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min
for patients with creatinine levels above institutional normal.
- For women of child-bearing potential, negative pregnancy test within 14 days prior to
starting treatment
- Men and women of childbearing age must be willing to use effective contraception while
on treatment and for at least 3 months thereafter
Exclusion Criteria:
- Treatment with TKI prior to developing metastatic disease
- Malignant pleural effusion or pleural disease
- Leptomeningeal disease or brain metastasis.
- Any site of disease that is not amenable to definitively local therapy including
surgery or radiation therapy
- Women who are breastfeeding or pregnant
- Concurrent malignancies other than non-melanoma skin cancer that require active
ongoing treatment.
- Any medical co-morbidities that would preclude surgery or radiation therapy
Maximum Eligible Age: | 99 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression free survival |
Time Frame: | 4 years |
Safety Issue: | |
Description: | Evaluate the effect of TKI with or without SBRT on progression free survival,to describe local control and out-of-field disease progression |
Secondary Outcome Measures
Measure: | Overall survival |
Time Frame: | 4 years |
Safety Issue: | |
Description: | To evaluate overall survival after SBRT followed by maintenance chemotherapy in comparison to maintenance chemotherapy alone. |
Measure: | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) |
Time Frame: | 4 years |
Safety Issue: | |
Description: | Using CTCAE system to evaluate toxicity profile |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Sichuan Provincial People's Hospital |
Last Updated
February 3, 2021